Asset development case studies

This case study explores two Bayesian model-assisted designs in the context of early phase oncology clinical trials, focusing on their application and impact on study design. It includes a review of each design’s operating characteristics, proposed amendments, and simulations.

A newly formed company needed expertise to support asset due diligence and strategic development planning to build their portfolio. ICON was asked to verify the company’s own due diligence assessments and requested ICON’s experience in designing and executing a more efficient clinical development programme.

For this client, ICON has performed technical evaluations of more than sixty assets across a range of therapeutic areas and modalities, including assessing the development risks and probability of achieving registration and commercial success.

A venture-backed biopharmaceutical company focused on therapies for rare diseases needed to accelerate late-stage development and commercialization. ICON provided technical and commercial assessments, collaborating closely to simplify the development program and develop ePROs and a novel biomarker approach for the rare disease asset.

ICON evaluated the probability of achieving regulatory approval of a stem cell therapy for the treatment of an acute immunological condition in adult and paediatric patients.